Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.There are warnings in the package insert that state this type of event can occur: under possible adverse effects, number 4 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 1 of 2 mdr's filed for the same event (reference 0001825034-2016-02351 and 3002806535-2016-00390).Product location unknown.
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